A Phase IIB, Multi-Dose, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis. - ND
- Conditions
- Psoriatic arthritisMedDRA version: 9.1Level: LLTClassification code 10032451Term: Other rheumatoid arthritis with visceral or systemic involvement
- Registration Number
- EUCTR2007-004241-15-IT
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 220
1) Signed Written Informed Consent. 2) Target Population a) meet Classification Criteria for Psoriatic Arthritis (CASPAR) (Appendix 3) for a duration of disease at least 3 months; b) prior failure of DMARD therapy (inefficacy or intolerance); if patient had prior failure of methotrexate, s/he must have been on at least 15 mg/week dose for at least 2 months; c) if recent failure of a TNFα blockade compound (inefficacy or intolerance), must be washed out prior to first dose: 56 days for infliximab and 28 days for etanercept and adalimumab; d) disease activity as defined by a tender joint count of ≥ 3, swollen joint count of ≥ 3 and clinically detectable synovitis at screening and Day 01 (prior to infusion); e) have active psoriasis with a qualifying target lesion ≥ 2 cm in diameter; f) Must be able to have MRI performed. 3) Age and Sex a) Men and women (not nursing and not pregnant) ≥ 18 years of age at the time of informed consent; b) Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 10 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Sex and Reproductive Status a) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 10 weeks after the last dose of investigational product b) Women who are pregnant or breastfeeding, or plan to become pregnant, or to start breastfeeding during the duration of the study c) Women with a positive pregnancy test on enrollment or prior to investigational product administration. 2) Medical History and Concurrent Diseases a) Subjects who are scheduled for or anticipate joint replacement surgery. b) Subjects who have a recent history of clinically significant drug or alcohol abuse c) Concomitant illness that in the opinion of the Investigator, is likely to require systemic glucocorticosteroid therapy during the study (e.g.; moderate to severe asthma) d) Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, pulmonary, cardiac, neurological, ophthalmologic or cerebral disease. Concomitant medical conditions that in the opinion of the Investigator might place the subject at unacceptable risk for participation in this study e) Subjects who are unwilling or unable to have screening performed based on current local or country guidelines/standards to evaluate the presence of cancer (e.g. breast, cervical, colon, prostate, hepatocellular, gastric). f) Subjects with a history or current evidence of malignancies; specifically, subjects with: a history of cancer within the last five years (other than non-melanoma skin cell cancers cured by local resection), or evidence of current malignancy or signs of possible malignancy detected by screening procedures for which the workup to exclude malignancy has not been completed or malignancy cannot be excluded. Female subjects who have had a manual examination or breast cancer imaging (mammogram, ultrasound, other method) screening study that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations (see Section 6.3.4). g) Subjects at risk for tuberculosis (TB). h) Subjects with any serious bacterial infection within the last 3 months, not treated and resolved with antibiotics, or any chronic bacterial infection (such as, but not limited to, chronic pyelonephritis, osteomyelitis and bronchiectasis) i) Subjects with evidence (as assessed by the Investigator) of active or latent bacterial or viral infections at the time of potential enrollment, including subjects with evidence of Human Immunodeficiency Virus (HIV). j) Subjects with herpes zoster or cytomegalovirus (CMV) that resolved less than 2 months prior to signing informed consent k) Subject who have received any live vaccines within 3 months of the anticipated first dose of study medication or who will have need of a live vaccine at any time, during and for 3 months after the duration of the study. 3) Physical and Laboratory Test Findings a) Subjects with Hepatitis B surface antigen. b) Subjects with Hepatitis C antibody-positive subjects who are also RIBApositive or PCR positive. c) Subjects with any of the following laboratory values: i. Hgb < 8.5 g/dL. ii. WBC < 3,000/mm3 (3 x 109/L) iii. Platelets < 100,000/mm3 (100 x 109/L). iv. Serum creatinine > 2 times upper limit of normal. v. Serum ALT or AST > 2 times upper limit of normal. vi. Any other laboratory test results that, in the opinion of the investigator, might place the subj
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method